The U.S. Food and Drug Administration (FDA) has released a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry.” The document provides clarification on FDA’s mandatory recall authority for cosmetics under section 611 of the FD&C Act, as established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Key points addressed in the draft guidance include:
- The criteria FDA may use to determine when a mandatory cosmetics recall is warranted
- The process FDA will follow when implementing a mandatory recall
- Industry expectations and responsibilities when a mandatory recall order is issued
Comment period:
FDA is accepting public comments until 60 days after publication in the Federal Register. You can review the guidance and submit commentary here.
Please note this draft guidance reflects FDA’s current thinking and is not binding when finalized.
